A new investigational cell therapy to address the root causes of Crohn’s disease and help restore balance in the body.
About
The RESTORE clinical trial is testing a type of treatment called cell therapy in people with moderate to severe treatment-refractory Crohn’s disease. The purpose of this clinical trial is to assess how safe and effective this investigational therapy is in people with moderate to severe Crohn’s disease who do not get better with existing treatment options.
The cell therapy that will be used in the RESTORE clinical trial is called TRX103. TRX103 is an allogeneic product (meaning it has been produced from healthy cells from donors other than the study participant) which has been developed by Tr1X.
Trial
Participants in this clinical trial will always be in the care of a doctor, who will monitor them closely throughout the entirety of the trial. For additional information, please see ClinicalTrials.gov.
Eligibility
In order to participate in this clinical trial, you must:
Be 18 to 65 years old.
Have active moderate to severe Crohn’s disease.
Have tried at least two advanced approved therapies for Crohn’s disease.
Not be pregnant or breast feeding, or plan to become pregnant within the next year.
This list does not include all of the trial participation criteria and details. For additional information, please see ClinicalTrials.gov.
Locations
University of Iowa Medical Center
200 Hawkins Drive, Iowa City, IA 52242
Principal Investigator
Dr. Steven Polyak, MD
Washington University Center for Advanced Medicine | Gastrointestinal Center
660 S. Euclid Ave St. Louis, MO 63110
Principal Investigator
Dr. Parakkal Deepak, MBBS, MS
Digestive Health Center at UW Medical Center – Montlake
1959 NE Pacific Street, 3rd Floor, Seattle, WA 98195
Principal Investigator
Dr. Scott Lee, MD
Gastroenterology Clinic | Taubman Center (University of Michigan)
1500 E Medical Center Drive, Floor 3 Reception D, Ann Arbor, MI 48109
Principal Investigator
Dr. Peter Higgins, MD, PhD
UofL Health
550 South Jackson St. Louisville, KY 40202
Principal Investigator
Dr. Susan Galandiuk, MD
UF Health
1600 SW Archer Road, 1st Floor, Stop #12, Gainesville, FL 32608
Principal Investigator
Dr. Angela Pham, MD
USF Health Morsani Center for Advanced Healthcare
13330 USF Laurel Drive, Tampa, FL 33612
Principal Investigator
Dr. Scott Adam Manski, MD
UChicago Medicine
5841 S Maryland Avenue, Chicago, IL 60637
Principal Investigator
Dr. David Rubin, MD
Northwestern Medicine
Galter Pavilion, 675 N St. Clair St. Chicago, IL 60611
Principal Investigator
Dr. Stephen Hanauer, MD
UC Davis Medical Center
Health Administrative Services Building 10850 White Rock Road Rancho Cordova, CA 95670
Principal Investigator
Dr. Maneesh Dave, MD
Gastroenterology Clinic (UCSF)
550 16th St. 5th Floor San Francisco, CA 94158
Principal Investigator
Dr. Sofia Verstraete, MD
Feinstein IBD Clinical Center
1 Gustave L Levy Pl New York, NY 10029
Principal Investigator
Dr. Ryan Ungaro, MD
Mayo Clinic - Minnesota
200 1st Street SW, Rochester, MN, 55905
Principal Investigator
Dr. Edward Loftus, Jr., MD
Mayo Clinic - Arizona
13400 E Shea Blvd, Scottsdale, AZ 85259
Principal Investigator
Dr. Manreet Kaur, MBBS, MD
Cleveland Clinic
9500 Euclid Avenue, Cleveland, OH 44195
Principal Investigator
Dr. Maliha Naseer, MD
FAQ
Crohn’s disease (CD) is a chronic inflammatory bowel disease.
Moderate to severe CD is generally classified as a score between 220 and 450 on the Crohn’s Disease Activity Index (CDAI) or a Simplified Endoscopic Score for CD (SES-CD) of 6 or higher.
Treatment-refractory CD is CD that continues to be inflamed despite two or more approved treatments, such as TNF-alpha inhibitors (Humira, Remicade, Cimzia), IL-12/23 inhibitors (Stelara, Skyrizi), anti-integrins (Entyvio, Tysabri) and/or JAK inhibitors (Rinvoq).
A clinical trial is a research study that looks to find a better way to prevent, diagnose or treat a disease by testing the safety and effectiveness of a new medical treatment. The US Food and Drug Administration (FDA) has strict rules regarding how a clinical trial is performed and reviews the data produced from it to decide if the investigational treatment can be widely used.
A Phase 1 clinical trial is the first step in testing a new treatment in humans. Phase 1 clinical trials typically seek to determine (i) how much of a treatment is safe to give, (ii) the optimal dose and timing of the treatment and (iii) which side effects (if any) are likely to be caused by the treatment.
In a Phase 2 clinical trial doctors want to understand if a treatment has a clinical benefit in addition to whether it is safe and well tolerated in humans.
Cell therapy refers to the transfer of new cells, or cells that have been modified in a laboratory to achieve particular characteristics, into the body to prevent or treat a disease. The two major types of cell therapy are autologous (in which the patient receives cells from their own body) and allogeneic (in which the patient receives cells from a healthy donor). This trial is using an allogeneic cell therapy.
TRX103 is the current name of an investigational therapy that contains a modified set of T cells from a healthy donor that mimic regulatory T cells. Regulatory T cells are the peacekeepers of your immune system, ensuring that it doesn't attack your own body by mistake. TRX103 is anallogeneic cell therapy product which has been developed by Tr1X.
If you are interested in participating in the RESTORE clinical trial, please either talk to your doctor, reach out to one of our clinical sites or contact Tr1X via the Contact Us section below for more information. You can also learn more at [ClinicalTrials.gov]
(*) indicates a required field.
All clinical trials have requirements that individuals need to meet to determine if they are eligible to participate. These requirements are explained in a document called an Informed Consent, which you will be asked to review and sign prior to undergoing medical screening. During the screening period you will undergo different study eligibility assessments and will be able to speak with one of the doctors running the trial to ensure that you understand and are comfortable with what it means to participate in the trial.
TRX103 is administered in a single intravenous (IV) infusion over the course of ~30 minutes.
Your TRX103 infusion will be followed by monitoring by your study doctor, and may include an overnight stay in the hospital. This is to see how well you are responding to TRX103 and if you experience any side effects.
You will need to return to the trial site periodically for follow-up visits with your doctor for up to 40 weeks after your TRX103 infusion, so that they can continue to monitor your health. Per US Food and Drug Administration (FDA) requirements, you will also be asked to take part in a separate long-term follow-up study so that you can be monitored for any possible side effects.
